Chromatography Method Developer (LC-MS & GC-MS)
4 days ago
Welwyn Garden City
Job Summary: We are looking for a highly motivated and skilled Analytical Method Development Analyst with hands-on experience in Agilent LC-MS and GC-MS systems, focusing on the development and validation of methods for Nitrosamine impurities in pharmaceutical substances and products. The candidate should have a strong understanding of regulatory expectations, impurity profiling, and analytical troubleshooting in a GMP-compliant environment. Key Responsibilities: • Develop, optimize, and validate analytical methods for the detection and quantification of Nitrosamine impurities using Agilent LC-MS/MS and Agilent GC-MS/MS systems (Triple Quadrupole or QTOF)., • Operate and maintain Agilent instrumentation, including system calibration, maintenance, and basic troubleshooting., • Use Agilent MassHunter software for data acquisition, processing, and reporting of LC-MS and GC-MS results., • Conduct method validation as per ICH Q2 (R1) guidelines, and prepare protocols and reports accordingly., • Perform risk-based impurity profiling for Nitrosamines based on synthetic pathway, excipient reactivity, and formulation interactions., • Execute forced degradation studies and assess potential nitrosamine formation under stress conditions., • Prepare and maintain technical documentation such as method development reports, SOPs, validation protocols/reports, and regulatory submission content., • Ensure compliance with GMP, GLP, and data integrity standards (ALCOA+) throughout all analytical activities., • Support regulatory audits and inspections by providing method details and data summaries related to nitrosamine testing., • Collaborate with cross-functional teams including QA, Regulatory Affairs, and Formulation Development. Qualifications: • M.Sc. / B.Pharm / M.Pharm in Analytical Chemistry, Pharmaceutical Chemistry, or related discipline., • 2–5 years of hands-on experience in method development using Agilent LC-MS and GC-MS, with a focus on Nitrosamine impurities., • Proficiency in Agilent MassHunter software (Qual, Quant, Optimizer) and OpenLab., • Sound knowledge of Nitrosamine risk assessment, ICH M7, and current regulatory guidance. Preferred Skills: • Experience with software like MassHunter and OpenLab., • Familiarity with structural elucidation using MS/MS fragmentation., • Knowledge of ICH M7 (R1), genotoxic impurities (GTIs), and carcinogenic risk assessment., • Experience with sample preparation techniques (e.g., derivatization, headspace analysis)., • Familiarity with LOD/LOQ requirements for Nitrosamines (ppb level sensitivity)., • Understanding of mass fragmentation patterns, ion source tuning, and matrix effect management. Soft Skills: • Strong analytical and problem-solving mindset., • Good communication and report-writing skills., • Ability to work independently and manage priorities effectively., • Team player with a proactive approach to learning and continuous improvement. Experience Level: Mid-Level